Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00219882
• Date of registration: 16/09/2005
• Prospective Registration: No
• Primary sponsor: Ramsey, Bonnie, MD
• Public title: Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis SEER
• Scientific title: A Phase I Safety and Dose Finding Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis Who Are Homozygous for Delta F508 Cystic Fibrosis Transmembrane Conductance Regulator (?F508 CFTR) Mutation
• Date of first enrolment: April 2005
• Target sample size: 11
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00219882
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Chris Goss, MD, MSc
• Affiliation: University of Washington

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female 18 - 40 years of age.

- Documented history of being homozygous for ?F508 CFTR genotype.

- Able to perform spirometry maneuvers, and have a forced expiratory volume at 1 second
(FEV1) greater than or equal to 30% of predicted normal for age, gender, and height
(Knudson standards) at screening.

- Oxygen saturation (as measured by pulse oximetry) > 90% on room air at screening.

- Clinically stable with no evidence of acute upper or lower respiratory tract
infection.

- Non-smoker for at least 6 months prior to screening.

- Able to understand and sign a written informed consent and comply with the
requirements of the study.

Exclusion Criteria:

- Diagnosis of acute pulmonary exacerbation (PE) requiring antibiotic intervention
within 4 weeks prior to screening.

- Patient reported history of viral upper respiratory tract infection within 2 weeks
prior to screening.

- History of major complications of lung disease (including recent massive hemoptysis
or pneumothorax) within two months prior to screening Visit.

- Acute nosebleeds within 14 days prior to screening.

- Nasal surgery within 4 weeks prior to screening.

- Begun use of nasal antibiotics, nasal steroids, nasal cromolyn, nasal atrovent, nasal
phenylephrine, or oxymetazoline within 14 days prior to screening.

- Chest x-ray at screening or within 3 months of screening with abnormalities
suggesting clinically significant active pulmonary disease other than cystic
fibrosis, and/or new CF-specific changes including atelectasis, small pneumothoraces,
or pneumonia.

- EKG at screening which shows clinically significant abnormality including prolonged
QTc, bundle branch block, rhythm other than sinus, evidence of ischemic heart
disease.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: standardized turmeric root extract

Primary Outcome(s)

Safety and tolerability of 14 days of treatment with orally administered curcuminoids as assessed by adverse events, laboratory parameters, and spirometry. [Time Frame: 14 days]

Secondary Outcome(s)

(1) Pharmacokinetics of repeated doses of orally administered curcuminoids. (2) Change in nasal potential difference (NPD) measurements. (3) Change in sweat chloride measurements. [Time Frame: 14 days]

Secondary ID(s)

SEER-106

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CF Therapeutics Development Network Coordinating Center

Seer Pharmaceuticals

Cystic Fibrosis Foundation Therapeutics